**SUMMARY**:The Validation Engineer will be responsible for performing and overseeing the validation of manufacturing processes. Support the quality assurance of all activities within the process, ensuring that all systems are running according to the specifications and operations standards monitoring budget, and controlling purchase and documentation**ESSENTIAL DUTIES AND RESPONSIBILITIES**- Lead/ support/conduct IQ, OQ, PQ validation studies of equipment and processes validations.- Select and utilize a wide range of appropriate statistical methodologies and techniques.- Give advice to project teams, develop/review and approve validation protocols and final reports.- Assist with/conduct validation studies.- Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process capability.- Generate and resolve protocol discrepancies or deviations.- Continually improve the Quality System Validation program.- Participate in project planning, scheduling, and tracking.- Develop and implement procedures to comply with corporate and industry standards.- Organize and archive validation documentation.- Provide validation training to Operations employees.- Mentor support, validation and staff engineers.- Support the response to customer quality concerns, following six-sigma methodology to determine root cause of problems and implementing sound corrective actions.- Perform gap analysis on previously performed validation/qualifications and if required, design and implement protocols to mitigate deficiencies in previous validation/qualifications.- Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer's specifications, operational procedures, calibration requirements and required maintenance.- Review equipment calibration and maintenance documentation and ensure Facilities is performing required calibration and maintenance in accordance with preset schedules.- Ensure change control procedures are being followed with respect to facility, equipment and utility changes and provide adequate oversight and follow-up on validation deviations both in terms of content (root cause) and in terms of CAPA.- Perform periodic assessment of validation/qualification procedures and policies. Write and edit validation/qualification protocols and SOPs.- Responsible for providing validation/qualification trending data to management.- Assist with client and QA audits by explaining validation and qualification activities performed at the site.- Support process improvement initiatives in Manufacturing Engineering (OPEX)- Other duties as assigned.**QUALIFICATIONS**:**EDUCATION and/or EXPERIENCE**:- A Bachelor's degree in a related engineering field such as Mechanical, Electrical, Industrial, Chemical or Material Science is required with 2+ years in Quality/Validation in Medical Device Industry Engineering roles working with validation, qualification of equipment experience or equivalent combination of education and experience.- Knowledgeable in computer programs including Microsoft Word and Excel.- Ability to learn how equipment functions and then design appropriate validation/qualification protocols.- Experience with Statistical Process Control methods (control charts, Cpk's etc.)- Knowledge of good manufacturing practices (GMP's) encompassing plastics extrusion lines, and calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.- Proficient in GD&T and metrology. Ability to read and interpret prints and tool designs.- Ability to troubleshoot solve problems independently or as part of a team.- Excellent verbal and written English (B2) communication skills - Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans.- Knowledge of Six Sigma is required and certification is a plus.**LANGUAGE SKILLS**:- Communicates well orally and can edit documents with proper grammar and sentence structure.- Ability to write technical correspondence in English and Spanish.- Ability to effectively present information one-on-one and small group situations to customers, clients and other employees of the organization.Pay: ¢22,000.00 - ¢32,000.00 per yearAbility to commute/relocate:- Cartago, Provincia de Cartago: Reliably commute or planning to relocate before starting work (required)**Language**:- English (preferred)
